karenitecin in treating patients with relapsed or refractory non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer

objectives: * determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy. * determine the effect of prior response to chemotherapy on response to this drug in these patients. * determine survival and failure-free survival of patients treated with this drug. * determine the toxicity profile of this drug in these patients. outline: patients are stratified according to response to prior chemotherapy (relapsed vs refractory). patients receive karenitecin iv over 60 minutes on days 1-5. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients with responding disease after 6 courses may receive 2 additional courses beyond best response. patients are followed every 3 months for 1 year and then every 6 months thereafter. projected accrual: a minimum of 45 patients (25 for stratum i and 20 for stratum ii) will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed relapsed or refractory non-small cell lung carcinoma (nsclc) * squamous cell carcinoma * basaloid carcinoma * adenocarcinoma * bronchoalveolar carcinoma * adenosquamous cell carcinoma * large cell carcinoma * large cell neuroendocrine carcinoma * giant cell carcinoma * sarcomatoid carcinoma * non-small cell carcinoma not otherwise specified * histologic or cytologic documentation of recurrence required if disease previously completely resected * must have had only 1 prior chemotherapy regimen, including adjuvant or neoadjuvant therapy for nsclc * at least 1 unidimensionally measurable lesion * at least 20 mm with conventional techniques or * at least 10 mm with spiral ct scan * lesions that are not considered measurable include the following: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * abdominal masses not confirmed and followed by imaging techniques * cystic lesions * tumor lesions in a previously irradiated area * controlled cns metastases allowed if patient is neurologically stable and off steroids patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 hepatic: * bilirubin no greater than 1.5 mg/dl renal: * creatinine no greater than upper limit of normal other: * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for mitomycin) * no prior irinotecan or other camptothecin drug * no other concurrent chemotherapy endocrine therapy: * see disease characteristics * no concurrent hormonal therapy except for non-cancer-related conditions (e.g., insulin for diabetes) * no concurrent steroids except for adrenal failure radiotherapy: * see disease characteristics * prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present * at least 4 weeks since prior radiotherapy * no concurrent palliative radiotherapy surgery: * see disease characteristics

Keywords: recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer